A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
- Conditions
- Intraventricular BlockHeart Failure
- Interventions
- Procedure: LOT-CRT groupProcedure: BiVP group
- Registration Number
- NCT06061627
- Brief Summary
BATTLE study has been designed as a prospective, multi-center, randomized, controlled trial. This study will enroll 83 patients with chronic heart failure accompanied by intraventricular block (NICD) over an estimated recruitment period of 3 years. An LOT-CRT group will be compared with a group of conventional BiVP in the follow-up of at least 6 months. The study aimed to compare the curative effect of LOT-CRT in preserving LV systolic function with traditional BiVP in chronic heart failure patients with NICD.
- Detailed Description
Cardiac resynchronization therapy is a standardized treatment strategy for patients with chronic heart failure complicated by wide QRS waves. With the continuous development of physiological pacing technology, traditional cardiac resynchronization therapy, namely biventricular pacing technology, is constantly challenged. Left bundle branch area pacing (LBBAP), as the main method of physiological pacing technology, is currently increasingly widely used in clinical practice. In recent years, research has mainly focused on heart failure patients with wide QRS waves such as non ischemic cardiomyopathy and typical left bundle branch block (LBBB). The recently published LBBP-RESYNC study was a randomized controlled study comparing left bundle branch pacing (LBBP) and biventricular pacing. The results showed that LBBP can achieve better improvement in left ventricular function compared to traditional biventricular pacing.
Compared with patients with typical LBBB, traditional biventricular pacing synchronized treatment is less effective in chronic heart failure patients accompanied by intraventricular block (NICD), which is closely related to the electrophysiological mechanism of LBBB. The blocking site of typical LBBB is generally located within the His bundle to the proximal end of the left bundle branch, while the distal end of the left bundle branch is relatively healthy. Therefore, LBBP can completely correct this type of LBBB and significantly narrow the QRS wave; The electrophysiological mechanism of NICD is relatively complex, and there may be multiple blocking sites, and LBBP cannot be completely corrected. How to improve the treatment efficacy and clinical prognosis of chronic heart failure patients with NICD is an important scientific issue that urgently needs to be solved. It is unclear whether left bundle branch pacing technology can provide support for cardiac function in such patients.
Traditional biventricular pacing combines right ventricular and left epicardial pacing; LBBAP combined with left ventricular epicardial pacing, also known as LOT-CRT, is an innovative pacing method. This study aims to explore the application value of LBBAP in patients with chronic heart failure and NICD.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86
- Ischemic or non ischemic cardiomyopathy
- Optimal medical therapy for at lest 3 months
- NYHA class II-IV
- LVEF≤35% as assessed by echocardiography
- Sinus rhythm (may have paroxysmal atrial fibrillation)
- QRS duration ≥ 150ms
- Intraventricular block (NICD), QRS morphology is neither LBBB nor RBBB
- Valvular heart disease that requires or has undergone surgical intervention
- After mechanical tricuspid valve replacement
- Persistent or permanent atrial fibrillation or atrial flutter
- Second or third degree atrioventricular block
- Have a history of acute myocardial infarction within 3 months prior to enrollment
- Patient's expected survival time is less than 12 months
- Pregnant or planned to conceive
- Ventricular septal hypertrophy (ventricular septal thickness exceeds 15mm at the end of diastole)
- Patients with simple and persistent left superior vena cava
- Patients with existing pacemaker implantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LOT-CRT group LOT-CRT group In this arm, an right artrial (RA) lead, an implantable cardioverter defibrillator (ICD) lead and a LV pacing lead are placed are conventionally implanted. A left bundle branch pacing(LBBP) lead is attempted to be placed. BiVP group BiVP group In this arm, an RA lead , an ICD lead and a LV pacing lead are placed.
- Primary Outcome Measures
Name Time Method Left ventricular ejection fraction(LVEF) Baseline; 6-month follow-up Changes from baseline LVEF(unit: %) assessed by echocardiography at follow-up
- Secondary Outcome Measures
Name Time Method Changes in concentration of NT-proBNP in blood between baseline and follow-up Baseline; 3-month, 6-month follow-up Blood test is performed at each time frame to determine the concentration of NT-proBNP(unit: pg/mL)
Paced QRS duration Postoperative day 1; 1-month,3-month and 6-month follow-up Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.
A combined clinical endpoint of all-cause mortality and heart failure hospitalization, 6-month follow-up Including date and number of all-cause mortalityand heart failure hospitalization,
Left ventricular end systolic volume(LVESV) Baseline; 3-month, 6-month follow-up Changes from baseline LVESV(unit: mL) assessed by echocardiography at follow-up
Left ventricular end diastolic volume(LVEDV) Baseline; 3-month, 6-month follow-up Changes from baseline LVEDV(unit: mL) assessed by echocardiography at follow-up
Left ventricular end systolic diameter(LVESD) Baseline; 3-month, 6-month follow-up Changes from baseline LVESD(unit: mm) assessed by echocardiography at follow-up
Left ventricular end diastolic diameter(LVEDD) Baseline; 3-month, 6-month follow-up Changes from baseline LVEDD(unit: mm) assessed by echocardiography at follow-up
Changes in New York Heart Association Heart Function Classification between baseline and follow-up Baseline; 3-month, 6-month follow-up The higher the classification, the more severe the heart failure symptoms(four levels: I, II, III and IV)
Changes in 6-minute Walk Distance between baseline and follow-up Baseline; 3-month, 6-month follow-up Distance that a participant walk within 6 minutes
Incidence of stroke events 6-month follow-up Including date and number of stroke
Success rate of LBBAP implantation Success rate of LBBAP implantation Success rate of LBBAP implantation Success rate of LBBAP implantation Success rate of LBBAP implantation Operative day Success rate of LBBAP in LOT-CRT group
Change in Quality Of Life Questionnaire score between baseline and follow-up Baseline; 3-month, 6-month follow-up Reflect the effect of cardiac funtion on quality of life, and higher scores represent a worse outcome
A combined arrhythmia endpoint of new-onset atrial fibrillation and malignant ventricular arrhythmia 6-month follow-up Including date and number of new-onset atrial fibrillation and malignant ventricular arrhythmia
Trial Locations
- Locations (1)
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China